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Objective To provide direction for the improvement of quality control of hospital preparations and ensure the safety for clinical use by analyzing the hospital preparation deviations in recent three years. Methods A retrospective analysis on 59 minor hospital preparation deviations from 2017 to 2019 was conducted. Brainstorming, fishbone drawing and, Minitab software were used to analyze the root causes of deviations from five aspects: personnel, machine, materials, methods and environment. The preventive and corrective measures were implemented. The results were evaluated. Results 1 significant deviation (1.7%), 24 major deviation (40.7%), and 34 minor deviation (57.6%) were identified among the 59 casses of preparation deviation. With the implementation of preventive and corrective measures, the total number of deviations in 2018 was significantly reduced compared to that in 2017. The total number of deviations in 2019 was about the same as that in 2018. The human factors need to be focused. Conclusion The pharmaceutical preparation deviations in our hospital have been reduced. The further quality improvements for pharmaceutical preparations will be carried out by following the regulations of pharmaceutical production quality management standards and pharmaceutical production supervision and administration measures.
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Objective To establish a high performance liquid chromatography(HPLC) method for simultaneous determination of the contents of 7 components of chlorogenic acid, caffeic acid, paeoniflorin, ammonium glycyrrhizinate, baicalin, baicalein, and wogonin in Piqin oral liquid. Methods A double-wavelength HPLC method was performed. The column was Agilent Zorbax SB-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase was 0.02% phosphoric acid aqueous solution (A)-acetonitrile (B) gradient elution; Flow rate: 1.0 ml/min; Column temperature: 35℃; Injection volume: 20 μl; Detection wavelength: 0-18.0 min, 325 nm (detect chlorogenic acid, caffeic acid); 18.0-65.0 min, 280 nm (detect paeoniflorin, baicalin, baicalein, ammonium glycyrrhizinate, wogonin). Results The chlorogenic acid, caffeic acid, paeoniflorin, ammonium glycyrrhizinate, baicalin, baicalein and wogonin were completely separated. Seven components have a good linear relationship between the peak area and concentration, with the recoveries between 96.41% and 99.70%. Conclusion This method is simple, accurate and reproducible, and can be used for the quality control of Piqin oral liquid.
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Objective To establish a method for simultaneous determination of chlorogenic acid, luteolin-7-O-β-D-glucoside,3,5-dicaffeoylquinic acid, linarin and pogostone in Fangshu Qingre mixture by RP-HPLC. Methods ZORBAX-SB-C18 column(4.6 mm×250 mm, 5 μm) was used as the chromatographic column.The mobile phase was 0.2% formic acid water solution(A) and acetonitrile solution (B)with a gradient elution mode. The flow rate was 1.0 ml/min.The detective wavelength was 327 nm. The column temperature was 30 ℃. Results There were good linear relationships in the determination of chlorogenic acid, luteolin-7-O-β-D-glucoside, 3,5-dicaffeoylquinic acid, linarin and pogostone (r≥0.999 6), with the average recovery rate of 102.03%(1.63%), 102.38%(1.51%), 102.39%(1.23%), 103.14%(1.87%) and 104.01%(2.33%). Conclusion The method was simple and stable with a good reproducibility, which could be used as a quality control method for active compotents in Fangshu Qingre mixture.
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Objective To establish a method for content determination of total flavones and polysaccharides in Fangshu Qingre mixture by UV-Vis Spectrophotometry. Methods The contents of total flavones and polysaccharides in Fangshu Qingre mixture were determined by UV-Vis spectroscopy with rutin and anhydrous glucose as reference substance, and the wavelength was set at 508 nm and 487 nm. Results The contents were from 0.00 to 59.20 μg/ml for total flavones and from 10.92 to 109.20 μg/ml for total polysaccharides in Fangshu Qingre mixture. The recoveries of total flavones and total polysaccharides were 104.4% and 104.8% respectively. Conclusion The method of using ultraviolet spectroscopy was simple, reproducible, accurate and reliable, which could be preferably used as the method for content determination of total flavones and polysaccharides in Fangshu Qingre mixture.
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Objective To establish a method for the determination of the total flavonoids content in compound Yinchen mixture by UV spectrophotometry .Methods Using rutin as comparison ,three coloration methods were studied to find the op-timal assay method .Results The sample was detected at 508 nm wavelength by NaNO2-Al(NO3 )3-NaOH reaction with rutin as reference .The rutin content had a liner relationship in the range of 0 .0125-0 .0626 g/L (n=9 ,r=0 .9999) ,and the aver-age recovery rate was 99 .49％ with RSD of 0 .84％ .Conclusion The NaNO2-Al(NO3 )3-NaOH coloration method is proved to be simple ,quick ,stable and reliable for the determination of total flavonoids in compound Yinchen mixture .
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Objective: To investigate the content of ethylparaben in potassium chloride solution.Methods: According to the guidance for antibacterial effect test stated in Chinese Pharmacopoeia(the 4th volume of 2015 edition), 5 standard bacterial strains including Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as the challenging strains.Using the logarithm decrease of bacteria number as the index, the antimicrobial effectiveness of ethylparaben at different concentrations was studied to screen out the optimal concentration in the solution.Results: The growth of the 5 standard bacterial strains was inhibited effectively by potassium chloride solution containing 0.05% ethylparaben, which was also the minimum effective concentration.Conclusion: 0.05% Ethylparaben is suitable as the bacteriostatic agent for potassium chloride solution.
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Objective:To establish a method for the content determination of triptolide, total diterpenoids and total alkaloids in Leigongteng oral solution to provide basis for the quality control. Methods:An HPLC analysis was used to detect the content of triptol-ide, which was carried out on an Eclipse XDB-C18 column (150 mm × 4. 6 mm, 5μm) with the mobile phase consisting of acetonitrile-water with gradient elution. The flow rate was maintained at 1. 0 ml·min-1 , the column temperature was kept at 40℃ and the detec-tion wavelength was set at 218 nm. Using triptolide and wilforine as the contrast, the total diterpenoids and total alkaloids were deter-mined by UV-Vis spectrophotometry. Results:There were good linear relationship in the determination of triptolide, total diterpenoids (caculated as triptolide) and total alkaloids (caculated as wilforine) (r≥0. 999 8), the average recovery were 91. 96%, 90. 56%, 99. 18%, and the RSD were less than 3%. Conclusion:The method is with good reproducibility and stability, which can be used for the quality control of Leigongteng oral solution.
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Objective:To establish the quality standard for compound Yinchen mixture. Methods:A TLC method was used to i-dentify Artemisiae scopariae Herba,Gardeniae Fructus, and Rhei Radix et Rhizoma in the mixture. An HPLC method was used to quan-titatively analyze the concentration of chlorogenic acid and geniposide. Results:The TLC spots were clear without any interference the negative control. The linear range of chlorogenic acid was 0. 04-0. 20 mg·ml-1 ,and that of geniposide was 0. 05-0. 25 mg·ml-1 . The average recovery of chlorogenic acid was 94. 4% with RSD of 1. 85%, and that of geniposide was 102. 2% with RSD of 1. 15%( n=6). Conclusion:The method is accurate,reliable,specific and reproducible,which can be used for the quality control of compound Yinchen mixtures.
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Objective:To establish an HPLC method for determining the content of aspirin and sodium salicylat in A-Liu spirits and study the stability of the two components under different storage conditions. Methods:The analytical column was Agilent Eclipse XDB-C18(150 mm ×4.6 mm, 5 μm) ,0.01 mol·L-1 potassium dihydrogen phosphate (adjusting pH to 2.3 with potassium acid) -acetonitrile-methanol(55∶15∶30) was used as the mobile phase at the flow rate of 1. 0ml·min-1 , the detection wavelength was 280 nm and the column temperature was 30℃. The contents of aspirin and sodium salicylat were regularly determined under such storage conditions as ambient temperature, constant temperature and humidity(30℃ ± 2℃,65% ± 5%) and refrigeration (4℃ ± 2℃). Re-sults:The average recovery and RSD were 100. 06% and 0. 80%(n=9) for aspirin, and 100. 53% and 0. 82%(n=9) for sodium salicylat. Aspirin and sodium salicylat showed good linear relationship within the range of 31.0-310.0 μg·ml-1(r=0.999 9)and 30. 5-305. 0 μg·ml-1(r=0. 999 5), respectively. Under the three storage conditions, the content of aspirin was decreased, while that of sodium salicylat was increased, suggesting the temperature could significantly affect the hydrolysis rate and content of aspirin Conclusion:The method is promising with good resolution, reproducibility and sensitivity. It is recommended that the method be used to determine the content of aspirin and sodium salicylat in A-Liu spirits, and aspirin isn't stable under different storage conditions.
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Objective:To establish an HPLC method to determine the content of chloramphenicol, salicylic acid and the related substances in compound chloramphenicol alcoholic solutions. Methods:The analytical column was Agilent Eclipse XDB-C18 (150 mm × 4. 6 mm,5 μm), 0. 8% acetic acid solution- acetonitrile(60∶40) was used as the mobile phase with the flow rate of 1. 0 ml· min-1 , the detection wavelength was 290nm for chloramphenicol and salicylic acid, and 272nm for the related substances, the column temperature was 25℃,and the injection volume was 10 μl. Results: Chloramphenicol and salicylic acid were completely separated from the related substances. The linear relationship of chloramphenicol ranged from 14. 88 to 297. 60μg·ml-1(r=0. 999 9), and the average recovery was 101. 18% with RSD of 0. 82%(n=9). The linear relationship of salicylic acid ranged from 9. 72 to 194. 40μg· ml-1(r=1. 000 0), and the average recovery was 99. 78% with RSD of 0. 27%(n=9). Conclusion:The method is good in resolu-tion, reproducibility and sensitivity. It is suitable for the determination of the two components and related substances in compound chloramphenicol alcoholic solutions.
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OBJECTIVE:To validate the determination method of the content of Morphine in Compound Glycyrrhiza oral solution. METHODS: Samples were detected by solid phase extraction-HPLC on Kromasil C8 column (250 mm?4.6 mm,5 ?m) with mobile phase consisted of 0.05 mol?L-1 KH2PO4-0.0 025 mol?L-1 C14H15NaO3S?2H2O-acetonitrile using gradient elution.The detection wavelength was 220 nm and the flow rate was 1.0ml.min-1.RESULTS:The linear range of morphine was 2.02～20.2 ?g?mL-1(r=0.999 7),and the average recovery was 99.0%(RSD=0.40%,n=9).CONCLUSION: The method is accurate,sensitive and stable,and accurate and reliable in determination results.